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WHY RHOFADE™ Cream?
• The proportion of patients achieving at least a 2-grade improvement on both the Clinician Erythema Assessment (CEA) and the Subject Self-Assessment (SSA) on day 29 were as follows: at hours 3, 6, 9, and 12 results in study 1 were RHOFADE™ Cream (n = 222) 12%, 16%, 18%, and 15% vs vehicle (n = 218) 6%, 8%, 6%, and 6%, and in study 2 were RHOFADE™ Cream (n = 224) 14%, 13%, 16%, and 12% vs vehicle (n = 221) 7%, 5%, 9%, and 6%.1
RHOFADE TM (oxymetazoline hydrochloride) Cream 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Potential Impacts on Cardiovascular Disease
Alpha-adrenergic agonists may impact blood pressure. RHOFADETM Cream should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.
Potentiation of Vascular Insufficiency
RHOFADETM Cream should be used with caution in patients with cerebral or coronary insufficiency, Raynaud’s phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome. Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop.
Risk of Angle Closure Glaucoma
RHOFADETM Cream may increase the risk of angle closure glaucoma in patients with narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop.
The most common adverse reactions for RHOFADE TM Cream were: application-site dermatitis 2%, worsening inflammatory lesions of rosacea 1%, application-site pruritus 1%, application-site erythema 1%, and application-site pain 1%.
Reference: 1. RHOFADETM Cream Prescribing Information, 2017.
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